1. health and fitness
2. therapy

[
research report
]
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JOSHUA A. CLELAND, PT, PhD1 • PAUL MINTKEN, DPT2,3 • AMY MCDEVITT, DPT2 • MELANIE BIENIEK, DPT4
KRISTIN CARPENTER, DPT5 • KATHERINE KULP, DPT6 • JULIE M. WHITMAN, PT, DSc7
Manual Physical Therapy and Exercise
Versus Supervised Home Exercise
in the Management of Patients With
Inversion Ankle Sprain: A Multicenter
Randomized Clinical Trial
TTSTUDY DESIGN: Randomized clinical trial.
TTRESULTS: Seventy-four patients (mean 
TTOBJECTIVE: To compare the effectiveness of
manual therapy and exercise (MTEX) to a home
exercise program (HEP) in the management of
individuals with an inversion ankle sprain.
TTBACKGROUND: An in-clinic exercise program
has been found to yield similar outcomes as an
HEP for individuals with an inversion ankle sprain.
However, no studies have compared an MTEX approach to an HEP.
TTMETHODS: Patients with an inversion ankle
sprain completed the Foot and Ankle Ability
Measure (FAAM) activities of daily living subscale,
the FAAM sports subscale, the Lower Extremity
Functional Scale, and the numeric pain rating
scale. Patients were randomly assigned to either
an MTEX or an HEP treatment group. Outcomes
were collected at baseline, 4 weeks, and 6 months.
The primary aim (effects of treatment on pain
and disability) was examined with a mixed-model
analysis of variance. The hypothesis of interest was
the 2-way interaction (group by time).
SD age, 35.1  11.0 years; 48.6% female) were
randomized into the MTEX group (n = 37) or the
HEP group (n = 37). The overall group-by-time interaction for the mixed-model analysis of variance
was statistically significant for the FAAM activities
of daily living subscale (P<.001), FAAM sports subscale (P<.001), Lower Extremity Functional Scale
(P<.001), and pain (P.001). Improvements in all
functional outcome measures and pain were significantly greater at both the 4-week and 6-month
follow-up periods in favor of the MTEX group.
TTCONCLUSION: The results suggest that an
MTEX approach is superior to an HEP in the
treatment of inversion ankle sprains. Registered at
clinicaltrials.gov (NCT00797368).
TTLEVEL OF EVIDENCE: Therapy, level 1b–.
J Orthop Sports Phys Ther 2013;43(7):443-455.
Epub 29 April 2013. doi:10.2519/jospt.2013.4792
TTKEY WORDS: manipulation, mobilization
I
nversion ankle sprains are
common among physically
active people, with an annual
incidence of 7 ankle sprain in­
juries per 1000 people.1,10,23,42,49,55,63
These injuries often occur as a result of
landing on a plantar flexed and inverted
foot.33 The foot twists medially in relation to the externally rotated tibia, often
causing injury to the lateral ligaments of
the ankle.1 This injury can occur during
sports, running on uneven surfaces, and
landing on an unbalanced foot after jumping.33 Most patients who have sustained
Department of Physical Therapy, Franklin Pierce University, Concord, NH; Rehabilitation Services, Concord Hospital, Concord, NH; Manual Physical Therapy Fellowship
Program, Regis University, Denver, CO. 2Physical Therapy Program, School of Medicine, University of Colorado-Denver, Aurora, CO. 3Wardenburg Health Center, University of
Colorado-Boulder, Boulder, CO. 4Rehabilitation Services, Concord Hospital, Epsom, NH. 5Waldron’s Peak Physical Therapy, Boulder, CO. 6Children’s Hospital Colorado, Aurora,
CO; Functional Physical Therapy, Denver, CO. 7Orthopedic Manual Physical Therapy Program and Musculoskeletal Management Program, Evidence in Motion, Louisville, KY. This
study was approved by the following Institutional Review Boards: Concord Hospital, Concord, NH; the Colorado Multiple Institutional Review Board, Aurora, CO; and the University
of Colorado-Boulder, Boulder, CO. The American Academy of Orthopaedic Manual Physical Therapists Orthopaedic Physical Therapy Products Grant provided funding for this
project. This organization played no role in the design, conduct, or reporting of the study or in the decision to submit the manuscript for publication. The authors certify that they
have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the article. Address
correspondence to Dr Joshua A. Cleland, Department of Physical Therapy, Franklin Pierce University, 5 Chenell Drive, Concord, NH 03301. E-mail: joshcleland@comcast.net t
Copyright ©2013 Journal of Orthopaedic & Sports Physical Therapy ®
1
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[
an inversion ankle sprain respond well
to conservative management; however,
some individuals continue to experience
pain and persistent disability at long-term
follow-up.18,28 In a general population of
patients with an inversion ankle sprain
presenting to primary care, Braun9 found
that 72% reported persistent symptoms
at the 6-month follow-up. Additionally, it
has been estimated that the reinjury rate
following an inversion ankle sprain may
be as high as 80%, suggesting the need
to identify the most effective management
strategies for this condition.56
It has been suggested that patients
with recurrent inversion ankle sprains
frequently demonstrate dysfunction at
the proximal tibiofibular,3,31 distal tibiofibular,34 talocrural,17 or subtalar joint.30
In addition, individuals with a history
of an inversion ankle sprain may exhibit
deficits in strength of the ankle inverters
and increased sway with single-leg stance
tested on a stable (eyes closed) or unstable surface.32 Addressing impairments
of the foot and ankle region in patients
with inversion ankle sprains may lead to
improved pain and function. It has been
demonstrated that following an inversion
ankle sprain, manual therapy techniques
(both thrust and nonthrust mobilization/manipulation) may be beneficial in
restoring or improving ankle dorsiflexion,3,13,15,29,51,59 posterior talar glide,59 stride
speed and step length,29 distribution of
forces through the foot,41 and pain.14 Only
a few clinical trials have investigated the
impact of manual therapy on improving
function in a population of patients with
inversion ankle sprain.3,14,51 Among them,
Pellow and Brantingham51 demonstrated
that 8 sessions of thrust manipulation
resulted in greater improvements in
function, as measured with a functional
evaluation scoring scale, at a 1-month
follow-up compared to placebo ultrasound. In a recent systematic review,
Brantingham et al8 concluded that limited evidence exists for manual therapy
plus exercise to improve outcomes in the
short term in this population. However,
we were unable to identify studies report-
research report
ing long-term outcomes.
In a recent study,62 a clinical prediction
rule was developed to identify patients
who had sustained an inversion ankle
sprain and were likely to benefit from
manual therapy and exercise (MTEX)
directed at the distal lower extremity.
Consecutive patients with inversion ankle
sprain underwent a standardized examination, followed by an intervention consisting of manual therapy, which included
both thrust and nonthrust manipulation
and general mobility exercises. In that
study, 64 of 85 patients (75%) met the
threshold for successful outcome.62 It has
been suggested that with a high pretreatment probability of success (75%) and a
low chance of harm, therapists should
consider utilizing the respective treatment approach, and a clinical prediction
rule is not needed to guide clinical decision making.27
In the previously published clinical
prediction rule derivation study,62 only
gentle ankle mobility exercises were
used. Although evidence supports the
use of general range-of-motion exercises in patients with an inversion ankle
sprain,18,19,22,40 a more comprehensive
exercise program that includes strengthening and proprioceptive retraining
may further enhance the treatment
effect.61 The authors of a recent systematic review52 reported a significant
improvement in functional outcomes
and reductions in the subjective report of
instability following proprioceptive training in patients with ankle ligament injury.
Other systematic reviews have concluded
that there is moderate evidence that neuromuscular training results in improved
function and decreased reinjury rates in
patients with inversion ankle sprains.7,20
In a randomized clinical trial utilizing a
progressive exercise regimen, Bassett and
Prapavessis2 concluded that a supervised
home-based exercise program resulted in
outcomes similar to those of 8 sessions
of in-clinic management. However, the
authors did not incorporate any form
of manual therapy into their in-clinic
management approach, which consisted
]
solely of exercise. Hence, data are insufficient to determine if a combined MTEX
program is superior to a home exercise
program (HEP) in the management of
inversion ankle sprains both in the short
and long term. The purpose of this multicenter randomized clinical trial was to
investigate the effects of MTEX compared to an HEP for the management of
patients with inversion ankle sprain.
METHODS
O
ver a 30-month period (January
2010-June 2012), consecutive patients with inversion ankle sprain
presenting at any of 4 physical therapy
clinics (Rehabilitation Services, Concord
Hospital, Concord, NH; Wardenburg
Health Center, University of ColoradoBoulder, Boulder, CO; Anschutz Medical
Campus, University of Colorado-Denver,
Aurora, CO; and Waldron’s Peak Physical Therapy, Boulder, CO) were screened
for eligibility criteria to participate in this
multicenter clinical trial. To be eligible to
participate, patients had to present with
current symptoms (the number of days
since injury was not restricted) associated with a grade 1 or grade 2 inversion
ankle sprain, as defined by the West Point
Ankle Sprain Grading System,28,33 to be
between the ages of 16 and 60 years, to
have a numeric pain rating scale (NPRS)
score greater than 3/10 in the last week,
and to have a negative result from the
Ottawa ankle rules.57 Patients were excluded if they exhibited contraindications to manual therapy, as noted in the
patient’s medical screening questionnaire
(eg, tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged history of
steroid use, or severe vascular disease).
Other exclusions included prior surgery
to the distal tibia, fibula, ankle joint, or
rearfoot region (proximal to the base of
the metatarsals); fracture; other absolute
contraindications to manual therapy;
insufficient English-language skills to
complete all questionnaires; or inability
to comply with the treatment and followup schedule. The study was approved by
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the Institutional Review Boards of the
following institutions: Concord Hospital, Concord, NH; the Colorado Multiple
Institutional Review Board, Aurora, CO;
and the University of Colorado-Boulder,
Boulder, CO. All patients provided informed consent prior to their enrollment
in the study. This trial was registered at
clinicaltrials.gov (NCT00797368).
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Therapists
Seven physical therapists (mean  SD
age, 42.7  15.4 years) participated in
the recruitment, examination, and treatment of the patients in this study. All participating therapists were provided with
a detailed manual of standard operations
and procedures that outlined all the study
procedures, and were trained in the study
procedures by 1 of the investigators (J.A.C.
and P.M.) who were orthopaedic clinical
specialists and fellows of the American
Academy of Orthopaedic Manual Physical
Therapists. The training session included
instruction in the administrative aspects
of the study (informed consent, subject
recruitment, etc) and specific training
in the performance of the examination
and treatment procedures, including the
manual physical therapy techniques and
the exercise program. The purpose of the
training was to ensure that the examination and treatment procedures were performed in a standardized fashion across
the 4 data-collection sites. Participating
therapists had a mean  SD of 17  15
years (range, 1-40 years) of clinical experience in the outpatient orthopaedic
physical therapy setting. Of the 7 physical
therapists, 4 (57%) were orthopaedic certified specialists and 3 (43%) were fellows
of the American Academy of Orthopaedic
Manual Physical Therapists. It was not
possible to blind the treating therapists
to the patients’ treatment group assignment due to the nature of the interventions provided.
Outcome Measures
After signing informed consent forms,
all patients provided a history, underwent a physical examination, and com-
pleted a number of self-report measures
at baseline. The historical items included questions pertaining to the onset of
symptoms, the distribution of symptoms,
aggravating and easing postures, mechanism of injury, prior treatments, and
prior history of ankle pain. The physical
examination consisted of items routinely
used in the physical therapy examination of the lower extremity and included
observation of posture, range-of-motion
and joint mobility assessment, and the
performance of provocation tests. The
physical examination items were used to
further determine if any contraindications to manual therapy were present and
to determine the rigor with which manual therapy techniques would be delivered.
The primary outcome measure was
the Foot and Ankle Ability Measure
(FAAM) activities of daily living (ADL)
subscale.45 Secondary outcome measures
included the FAAM sports subscale,45
the Lower Extremity Functional Scale
(LEFS),6 and the NPRS.38 Patients completed all outcome measures at baseline
and at 4-week and 6-month follow-up
periods. The FAAM45 is a region-specific,
self-report questionnaire with 2 subscales. The ADL subscale consists of 21
questions, each with a Likert response
scale ranging from 4 (no difficulty) to 0
(unable to do the activity). Individuals
can also mark “N/A” in response to any
of the activities listed. Items marked N/A
are not scored. The scores for all items
are added together. The number of questions with a response is multiplied by
4 to get the highest potential score. If
all questions are answered, the highest
possible score is 84; if 1 question is not
answered, the highest possible score is
80; if 2 questions are not answered, the
highest possible score is 76, etc. The total score for the items is divided by the
highest possible score and multiplied by
100 to obtain a percentage. Higher scores
indicate higher levels of function.45 The
sports subscale is scored separately (highest possible number of points is 28) using
the same method as that described for the
ADL subscale. Both the FAAM ADL and
FAAM sports subscales have been shown
to exhibit excellent test-retest reliability and validity when compared to the
Medical Outcomes Study 36-Item Short
Form Health Survey physical functioning
subscale in individuals with leg, ankle,
and foot disorders.45 The minimal clinically important difference (MCID) for
the FAAM ADL subscale is 8 percentage points (0%-100% scale) and for the
sports subscale is 9 percentage points
(0%-100% scale).45
The LEFS consists of 20 questions,
and the highest possible score is 80.6
Higher scores indicate greater levels of
function. The LEFS has been shown to
have excellent validity, test-retest reliability, and responsiveness to change
in patients with lower extremity disorders,6,44,60 and to have an MCID of 9
points.6
An 11-point NPRS was used to measure pain intensity. The scale is anchored
on the left by 0 as “no pain” and on the
right by 10 as “worst imaginable pain.”
The NPRS has been shown to be reliable
and valid.21,36-39,53 Patients rated their current level of pain and their worst and least
amount of pain in the previous 24 hours.
The average of the 3 ratings was used to
represent the patient’s level of pain. The
NPRS has been shown to be reliable and
valid in patients with low back pain11 and
neck pain.12 However, this has yet to be
examined in a population with inversion
ankle sprains. The MCID for the NPRS
has been reported to be 2 points.24
In addition to the aforementioned
self-report measures, patients also completed a 15-point global rating of change
(GRC) scale at the 4-week and 6-month
follow-up periods. The GRC scale, originally described by Jaeschke et al,35 was
completed by each patient to rate their
own perception of improved ankle function. The scale ranges from –7 (“a very
great deal worse”) to 0 (“about the same”)
to +7 (“a very great deal better”). Intermittent descriptors of worsening or improving are assigned values from –1 to –6
and +1 to +6, respectively. At the 6-month
follow-up, patients were also asked if they
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[
experienced a recurrence of their inversion ankle sprain since the time of their
enrollment in the study. In an attempt
to ascertain adherence to their HEP, patients were also asked, “What percentage
of the time did you complete your home
exercise program?”
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Randomization
Once the baseline assessment was completed, patients were randomly assigned
to receive either MTEX or an HEP. Concealed allocation to treatment group was
performed by an individual not involved
in subject recruitment, using a computergenerated randomized table of numbers
created for each participating site prior to
the beginning of the study. The group assignment was recorded on an index card.
This card was folded in half such that the
label with the patient’s group assignment
was on the inside of the fold. The folded
index card was then placed inside the
envelope, and the envelope was sealed.
A second therapist, blinded to the baseline examination findings, opened the
envelope and proceeded with treatment
according to the group assignment. All
patients received treatment on the day of
the collection of baseline measurements
and enrollment in the study.
Interventions
Patients in the HEP group were seen
by a physical therapist for 4 sessions (1
per week) focusing on progression of the
exercise regimen. Patients in the MTEX
group were treated by a physical therapist
twice weekly for 4 weeks, for a total of 8
therapy sessions. Each treatment session
lasted 30 minutes for both treatment
groups. Both groups received advice to
stay active, as well as education on ice,
compression, and elevation. Due to the
nature of the interventions, it was not
possible to blind the patients to group
assignment.
HEP Group Patients attended physical
therapy for 4 sessions for instruction and
progression of exercise. The first instruction occurred on the day of enrollment in
the trial and was based on the status of
research report
the patient and clinical decision making
of the therapist. Patients returned to the
clinic once a week for the next 3 weeks
for instruction on exercise progression.
On the first day of treatment, the patient began mobilizing and strengthening exercises based on patient status and
tolerance, as described by Bassett and
Prapavessis,2 which included the following: mobilizing exercises for the foot and
ankle, gentle strengthening exercises,
resistive-band exercises, body-weight
resistance exercises, 1-leg standing activities, standing on balance board, and
weight-bearing functional activities.
Specific details regarding exercises and
indicators for progression are provided
in APPENDIX A.
The exercise progression was based on
feedback from the patient and the clinical
decision making of the therapist. Patients
in this group were asked to perform the
above exercise regimen at home once daily for the duration of the study. Patients
were also instructed to continue normal
activities that do not increase symptoms,
and to avoid activities that aggravate
symptoms. At each visit with a physical
therapist, patients were asked if they had
experienced any adverse events from the
exercise program. At the fourth and final
visit (week 4), patients were instructed to
continue with strengthening and balance
activities.
MTEX Group At each session, the physical
therapist delivered manual physical therapy interventions that were originally used
in a prospective cohort study by Whitman
et al.62 The following descriptions of the
manipulations are consistent with the
model proposed by Mintken et al48:
•Proximal tibiofibular joint: high-velocity, end-range anterior force to the
head of the fibula on the tibia through
end-range flexion and external rotation of the knee in a supine position.
•Distal tibiofibular joint: low-velocity,
mid- to end-range anterior-to-posterior oscillatory force to the distal fibula
and/or tibia in a supine position, with
slight ankle plantar flexion.
•Talocrural and subtalar joints: high-
]
velocity, end-range longitudinal traction force to the dorsum of the foot
on the lower leg in a supine position,
with ankle dorsiflexion and eversion.
Low-velocity, mid- to end-range anterior-to-posterior oscillatory force
to the talus on the distal tibiofibular
joint in a supine position, with varying
amounts of ankle dorsiflexion. Lowvelocity, mid- to end-range medial-tolateral oscillatory force to the medial
side of the talus (or calcaneus) on the
lower leg in a left sidelying position.
Low-velocity, end-range anterior-toposterior sustained glide to the talus
in a weight-bearing position, with active ankle dorsiflexion and knee flexion in an on/off fashion.
These techniques are described in
detail in APPENDIX B. The goal of the lowvelocity manual physical therapy interventions was for the clinician to perform
grades III to IV, as described by Maitland
et al,43 for five 30-second bouts. However,
the therapist was allowed to modify the
grade of manual therapy (I-IV) to maximize patient comfort with the technique.
On the first day of treatment, the patients began the exact same mobilizing
and strengthening exercises, as described
by Bassett and Prapavessis,2 that the HEP
group received (APPENDIX A). The exercise
progression was based on feedback from
the patient and the clinical decision making of the therapist. Patients in this group
were asked to perform the above exercise
regimen at home once daily for the duration of the study. Patients in this group
were also instructed to perform 2 selfmobilization techniques at home (ankle
eversion self-mobilization and weightbearing dorsiflexion self-mobilization),
as described by Whitman et al.62 Patients
were also instructed to do all activities
that did not increase symptoms and to
avoid activities that aggravated symptoms. At each therapy session with a
physical therapist, patients were asked if
they had experienced any adverse events
from the exercise program or manual
physical therapy interventions. Upon
discharge from therapy, all patients were
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instructed to continue with strengthening and balance activities.
Consecutive patients with an inversion
ankle sprain screened for eligibility,
n = 157
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Follow-up
At the final physical therapy session (4week follow-up) and at the 6-month
follow-up, patients in both groups completed the FAAM ADL, FAAM sports,
LEFS, NPRS, and GRC. Self-report
questionnaires were administered at the
4-week follow-up by an individual who
was blind to group assignment, and were
mailed to the subjects at the 6-month
follow-up.
Not eligible, n = 67
• Presented with
contraindications, n = 17
• Previous surgery, n = 2
• NPRS score <3, n = 31
• Unable to follow treatment
schedule, n = 11
• Did not satisfy age
requirements, n = 6
Eligible, n = 90
Sample Size
Declined, n = 16
The calculations were based on detecting
an 8% difference in the FAAM ADL at
the 4-week follow-up, assuming a standard deviation of 11%, a 2-tailed test,
and an alpha level equal to .05 and 80%
power. This generated a sample size of 32
patients per group. Allowing for a conservative dropout rate of approximately 15%,
we recruited 74 patients into the study.
Data Analysis
Descriptive statistics, including measures
of central tendency and dispersion, were
calculated for baseline demographic data.
Frequency distributions were estimated
for categorical data. Baseline demographic data were compared between treatment groups using independent t tests for
continuous data and chi-square tests of
independence for categorical data to assess the adequacy of the randomization.
Patients were also categorized according
to their stages of injury as follows: acute,
less than 6 weeks’ duration; subacute, 6
to 12 weeks’ duration; chronic, greater
than 12 weeks’ duration.
The primary aim, the effects of treatment on disability and pain, was examined with a 2-by-3 mixed-model analysis
of variance (ANOVA), with treatment
group (MTEX versus HEP) as the between-subject factor and time (baseline,
4-week follow-up, 6-month follow-up)
as the within-subject factor. Separate
ANOVAs were performed with the FAAM
ADL, FAAM sports, LEFS, and NPRS as
Agreed to participate and signed
informed consent, n = 74
Random assignment
MTEX group, n = 37
HEP group, n = 37
4-wk follow-up, n = 34
Dropout, n = 3
• Moved, n = 1
• Cost of care too high, n = 1
• Unable to make time
commitments, n = 1
4-wk follow-up, n = 35
Dropout, n = 2
• Did not return, n = 1
• Unable to make time
commitments, n = 1
6-mo follow-up, n = 33
Dropout, n = 1
• Did not return follow-up
questionnaires, n = 1
6-mo follow-up, n = 32
Dropout, n = 3
• Did not return follow-up
questionnaires, n = 3
FIGURE 1. Flow diagram of patient recruitment and retention. Abbreviations: HEP, home exercise program; MTEX,
manual therapy and exercise; NPRS, numeric pain rating scale.
the dependent variable. For each ANOVA, the hypothesis of interest was the
2-way group-by-time interaction. To determine if missing data points associated
with dropouts were missing at random or
missing for systematic reasons, we performed the Little missing completely at
random test.54 Intention-to-treat analysis was performed by using expectation
maximization, whereby missing data are
computed using regression equations.54
Planned pairwise comparisons were performed examining the difference between
baseline and follow-up periods, using the
Bonferroni equality at an alpha level of
.05. A Mann-Whitney U test was used to
determine a difference in the GRC between groups at the 4-week and 6-month
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RESULTS
O
ne hundred fifty-seven patients with inversion ankle sprain
were screened for eligibility to participate in this clinical trial. Seventy-four
patients (mean  SD age, 35.1  11.0
years; 48.6% female) met the eligibility
criteria, agreed to participate, and signed
informed consent. Of these 74 patients,
37 were randomized to the HEP group
and 37 were randomized to the MTEX
group. FIGURE 1 shows a flow diagram of
patient recruitment and retention for
this trial. All baseline demographics were
similar between groups (P>.05) (TABLE 1).
Of the 74 patients enrolled, 69 (93.2%)
completed the 4-week follow-up and 65
(87.8%) completed the 6-month followup (FIGURE 1). The percentages of dropouts
at 4 weeks and at 6 months were not statistically different between treatment
groups.
The overall group-by-time interaction for the mixed-model ANOVA was
statistically significant for the FAAM
ADL (P.001), FAAM sports (P<.001),
LEFS (P.001), and pain (P.001). Between-group differences revealed that the
MTEX group experienced statistically
significantly greater improvement in the
FAAM ADL and FAAM sports subscales
at both the 4-week (FAAM ADL mean
difference, 11.7; 95% confidence interval
[CI]: 7.4, 16.1; FAAM sports mean difference, 13.3; 95% CI: 8.0, 18.6, respectively) and 6-month (FAAM ADL mean
difference, 6.2; 95% CI: 0.98, 11.5; FAAM
sports mean difference, 7.2; 95% CI: 2.6,
11.8) follow-up periods. Similarly, sig-
]
Demographics and Outcome Measures at Baseline
TABLE 1
Variable
HEP (n = 37)*
MTEX (n = 37)*
P Value
33.2  9.8
37.1  11.8
.12†
Gender (female), n (%)
19 (51)
17 (46)
.81‡
Duration of symptoms, d
59.9  31.3
72.1  67.7
.32†
Acute (<6 wk), n
11
12
Subacute (6-12 wk), n
22
17
Age, y
Chronic (>12 wk), n
.37‡
4
8
NPRS (0-10)§
3.9  0.9
3.9  0.7
.99†
LEFS (0-80)
53.8  7.2
51.1  8.7
.16†
FAAM ADL (0%-100%)
63.5  12.5
65.8  9.7
.39†
FAAM sports (0%-100%)
49.9  9.4
49.3  8.0
.76†
7 (18.9)
5 (13.5)
.75‡
Taking medications at the start
of the study, n (%)
Abbreviations: ADL, activities of daily living; FAAM, Foot and Ankle Ability Measure; HEP, home
exercise program; LEFS, Lower Extremity Functional Scale; MTEX, manual therapy and exercise;
NPRS, numeric pain rating scale.
*Values are mean  SD unless otherwise indicated.
†
Independent-samples t tests.
‡
Chi-square tests.
§
Lower score is better. In all other scales, higher score is better.
100
90
80
70
60
50
40
30
20
10
0
*
*
FAAM, %
follow-up periods. An independent t test
was used to determine if a difference existed between groups for adherence to the
exercise regimen, and a chi-square analysis was used to examine the number of
recurrences between groups. The alpha
level for all analyses was a priori established at .05 using a 2-tailed test. Data
analyses were performed using the SPSS
Version 20.0 statistical software package
(SPSS Inc, Chicago, IL).
research report
FAAM, %
[
Initial
4 wk
MTEX
100
90
80
70
60
50
40
30
20
10
0
*
*
Initial
6 mo
4 wk
MTEX
HEP
6 mo
HEP
FIGURE 2. Mean  SD FAAM activities of daily living
subscale scores at each assessment point. The
scale ranges from 0% to 100%, with higher scores
indicating better function. *Significant difference
between groups (P<.05). Abbreviations: FAAM,
Foot and Ankle Ability Measure; HEP, home exercise
program; MTEX, manual therapy and exercise.
FIGURE 3. Mean  SD FAAM sports subscale scores
at each assessment point. The scale ranges from 0%
to 100%, with higher scores indicating better function.
*Significant difference between groups (P<.05).
Abbreviations: FAAM, Foot and Ankle Ability Measure;
HEP, home exercise program; MTEX, manual therapy
and exercise.
nificant between-group differences for
improvement existed for the LEFS at 4
weeks (mean difference, 12.8; 95% CI:
9.1, 16.5) and at 6 months (mean difference, 8.1; 95% CI: 4.1, 12.1), both favoring the MTEX group. FIGURES 2 through
4 show the scores at each time frame
for the FAAM ADL, FAAM sports, and
LEFS, respectively.
There was also a significant difference
in favor of greater improvements in pain
for the MTEX group at both the 4-week
(mean difference, –1.2; 95% CI: –1.5,
–0.90) and 6-month (mean difference,
–0.47; 95% CI: –0.90, –0.05) followup periods (TABLE 2). FIGURE 5 shows the
scores at each time frame for the NPRS.
The Mann-Whitney U test revealed a significant difference in favor of the MTEX
group for the GRC at both the 4-week
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Variable*
4 wk
MTEX
6 mo
Home Exercise Program†
Manual Therapy
and Exercise†
Between-Group
Differences‡
Baseline to 4 wk
9.6 (6.5, 12.6)
21.3 (18.2, 24.5)
11.7 (7.4, 16.1)§
Baseline to 6 mo
24.6 (20.5, 28.7)
30.8 (27.4, 34.2)
6.2 (0.98, 11.5)║
FAAM sports (0%-100%)
HEP
FIGURE 4. Mean  SD LEFS scores at each
assessment point. The scale ranges from 0 to 80, with
higher scores indicating better function. *Significant
difference between groups (P<.05). Abbreviations:
LEFS, Lower Extremity Functional Scale; HEP, home
exercise program; MTEX, manual therapy and exercise.
Baseline to 4 wk
13.8 (10.9, 16.8)
27.1 (22.7, 31.6)
13.3 (8.0, 18.6)§
Baseline to 6 mo
33.5 (30.7, 36.3)
40.7 (37.0, 44.4)
7.2 (2.6, 11.8)¶
Baseline to 4 wk
5.6 (3.1, 8.1)
18.4 (15.5, 21.2)
12.8 (9.1, 16.5)§
Baseline to 6 mo
17.3 (14.5, 20.0)
25.3 (22.3, 28.3)
8.1 (4.1, 12.1)§
Baseline to 4 wk
–1.5 (–1.8, –1.3)
–2.7 (–2.9, –2.5)
–1.2 (–1.5, –0.90)§
Baseline to 6 mo
–3.1 (–3.5, –2.8)
–3.6 (–3.9, –3.4)
–0.47 (–0.90, –0.05)#
LEFS (0-80)
NPRS (0-10)
(MTEX group mean, 4.1; median, 4.0;
mode, 4.0; and HEP group mean, 3.0;
median, 3.0; mode, 3.0; P<.001) and
6-month (MTEX group mean, 6.3; median, 6.0; mode, 7.0; and HEP group mean,
4.4; median, 4.6; mode, 5.0; P<.001) follow-up periods.
No adverse events were reported for
either group during the study period.
There was no statistically significant difference in the recurrence of ankle sprain
rate (P = .48) between the MTEX (3/33,
9.1%) and HEP (5/32, 15.6%) groups.
Furthermore, there was no statistically
significant difference (P = .56) for the
percentage of patients who reported completing their home exercises between the
MTEX group (mean, 69.3% completion
rate) and the HEP group (mean, 65.5%
completion rate).
DISCUSSION
T
Changes in Pain and Function
for the 2 Interventions
FAAM ADL (0%-100%)
Initial
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TABLE 2
*
*
he results of the current study
demonstrate that both groups experienced improvements in pain and
function during the study period. However, the patients in the MTEX group exhibited significantly greater improvements
in pain and function at both 4 weeks and
6 months as compared to those in the
HEP group. Although point estimates of
between-group effect sizes for treatment
benefit suggest clinically meaningful benefits of MTEX over an HEP, widths of the
Abbreviations: ADL, activities of daily living; FAAM, Foot and Ankle Ability Measure; LEFS, Lower
Extremity Functional Scale; NPRS, numeric pain rating scale.
*Higher scores on the functional scales indicate improvement, and lower scores on the pain scale
indicate less pain.
†
Values are within-group mean (95% confidence interval) differences over time.
‡
Values are mean (95% confidence interval) differences in within-group changes between groups at
each time occasion.
§
P<.001.
║
P = .02.
¶
P = .002.
#
P = .03.
CIs around these estimates (with the exception of the LEFS at 4 weeks) fail to
provide completely convincing evidence
for a clinically meaningful advantage
(greater than MCID) for MTEX in the
target population. Though the betweengroup differences did not surpass the
MCIDs at 6 months, we believe that clinicians should consider using a multimodal
approach incorporating manual physical
therapy interventions and exercise for
the management of patients with inversion ankle sprain, based on the fact that
the within-group average improvements
(as well as the lower bound of their 95%
CIs) for the patients in the MTEX group
exceeded the MCIDs at both the 4-week
and 6-month follow-ups. Furthermore,
although the difference between groups
for recurrence rates was not statistically
significant, the HEP group experienced
almost double the rate of recurrence compared to the MTEX group (15.6% versus
9.1%), which may be clinically relevant.
6
5
4
NPRS
LEFS
90
80
70
60
50
40
30
20
10
0
*
3
2
*
1
0
Initial
4 wk
MTEX
6 mo
HEP
FIGURE 5. Mean  SD NPRS scores at each
assessment point. The scale ranges from 0 to 10,
with lower scores indicating less pain. *Significant
difference between groups (P<.05). Abbreviations:
HEP, home exercise program; MTEX, manual therapy
and exercise; NPRS, numeric pain rating scale.
The findings from the current study
differ from those reported by Bassett and
Prapavessis,2 who compared a mean of
7.6 sessions of supervised in-clinic exercise with a physical therapist to 4.6 sessions of supervised HEP progression. In
contrast to our results, showing superior
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[
results with an MTEX approach over
an HEP, the results in the Bassett and
Prapavessis2 trial revealed no statistically significant difference between the
groups at the completion of treatment.
It is possible that the inclusion of manual physical therapy interventions in the
treatment approach in our trial was the
primary reason for the different findings
between studies. However, Bassett and
Prapavessis2 also included strategies to
enhance adherence to the HEP, which included educational materials, a treatment
booklet, and cognitive-behavioral interventions. These strategies were not used
in the current study and could have led to
greater improvements in the HEP group
in their study. Bassett and Prapavessis2
reported adherence to the HEP using a
1-to-5 scale (1 is no, 5 is all), whereas we
asked the patients to report their percentage of adherence. Therefore, direct
comparisons regarding exercise adherence between studies cannot be made.
Although it is expected that increased
adherence to home exercise would result
in better clinical outcomes, very few studies have examined this potential association.46 Future studies should examine
whether exercise adherence contributes
to better outcomes.
The results of the current study further support the conclusions of a systematic review by Brantingham et al8 that
MTEX is effective in the short term for
reducing pain and improving function in
patients with an inversion ankle sprain.
This is in contrast to the findings of Beazell and colleagues.3 They examined the
benefits of a joint manipulation applied to
either the proximal or distal tibiofibular
joint versus no treatment in patients with
chronic ankle instability, and their results
revealed that all 3 groups showed similar
improvement in dorsiflexion range of motion and function. Perhaps the difference
between the current study and that of
Beazell et al3 is the fact that their population had chronic symptoms and received
only 1 intervention technique. However,
our sample included 12 patients in the
chronic stage (greater than 12 weeks)
research report
who exhibited improvements within our
trial, suggesting that the current study’s
MTEX approach might be beneficial for
individuals with ankle inversion sprain,
regardless of the time since injury. Similarly, the authors of a recent study14 that
examined the impact of a 30-second
bout of grade III anterior/posterior talocrural joint mobilization in patients with
acute inversion ankle sprains reported
no better improvements in dorsiflexion
or function at a 24-hour follow-up as
compared to a control group. As only 1
manual therapy technique was used for a
single session, this suggests that multiple
treatment sessions utilizing a variety of
manual therapy techniques may be necessary to significantly improve function,
or that a combination of manual therapy
and exercises may increase the potential
to maximize patient outcomes.
The exact mechanism by which manual therapy achieves its effects is unknown,
but there are possible explanations worth
considering. It has been reported that
patients with an inversion ankle sprain
often exhibit impairments at joints that
contribute to ankle mobility, including
the proximal tibiofibular, distal tibiofibular,34 talocrural,17 and subtalar joints.30
Perhaps manual therapy is helpful in restoring motion at these joints, leading to
improved foot and ankle mechanics, less
pain, and improved function. It is also
possible that the effects of manual therapy are neurophysiological in nature.4,5
For example, it has been demonstrated
that the soleus and peroneal muscles exhibit arthrogenous muscle inhibition in
patients with ankle instability.47,50 The
authors of these studies have suggested
that this might be the result of altered
mechanoreceptors following the ankle
sprain, leading to a disrupted neural
feedback system to the dynamic stabilizers of the ankle. Interestingly, Grindstaff et al31 demonstrated that patients
with chronic ankle instability who were
treated with manipulation to the distal
tibiofibular joint exhibited increased soleus activation. Perhaps manual therapy
interventions stimulate mechanorecep-
]
tors and thereby assist the improvement
of neural feedback, which may aid in
dynamic stability and maximize the benefits of therapeutic exercise. Additionally, it is plausible that manual therapy
interventions could result in a reduction
of inflammatory cytokines,58 an increase
in beta endorphins,16 and hypoalgesia.25,26
These hypotheses require further scientific investigation.
There are a number of limitations to
the current study that should be considered. First, the study did not include a
comparison group that received either
no treatment (control) or a placebo intervention. Therefore, we cannot determine
what percentage of the improvements
made by the patients enrolled in the current trial was a result of the interventions they received, placebo, or simply
the natural history of the disorder. Additionally, the physical therapists spent
twice as much time with the patients in
the MTEX group as they did with those
in the HEP group. This in itself could
have contributed to the differences between groups. It should also be recognized that the therapists had no physical
contact with the patients in the HEP
group and that the power of touch might
also have contributed to the differences
in outcomes between groups. Smoking
was not captured as a baseline variable,
hence it is not known if this contributed
to a poorer prognosis for some individuals. Future studies should include a comparison group receiving no intervention
and, potentially, a placebo group, and
should ensure that equal time is spent
with individuals in each treatment group.
CONCLUSION
I
n this randomized clinical trial, a
management approach incorporating
MTEX for individuals with inversion
ankle sprain resulted in greater improvements in pain and function in both the
short and long term as compared to the
use of an HEP. Although both groups exhibited improvement, the MTEX group
experienced greater changes over time
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6/19/2013 12:30:50 PM
that were not only statistically significant but also surpassed the MCID of the
various outcome measures at the 4-week
follow-up. t
KEY POINTS
5.
6.
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Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
FINDINGS: In this randomized clinical
trial, a management approach incorporating MTEX for individuals with inversion ankle sprain resulted in greater
improvements in pain and function in
both the short and long term as compared to the use of an HEP.
IMPLICATIONS: Incorporating both manual
therapy and exercise into a multimodal
treatment program for the management
of patients with inversion ankle sprain
should be considered.
CAUTION: Attention bias might have been
partially or fully responsible for the differences between groups.
7.
8.
9.
10.
ACKNOWLEDGEMENTS: The American Academy
of Orthopaedic Manual Physical Therapists
Orthopaedic Physical Therapy Products
Grant provided funding for this project. This
organization played no role in the design,
conduct, or reporting of the study, or in the
decision to submit the manuscript for publication. We would also like to thank all the
therapists who participated in data collection
for this clinical trial.
11.
12.
13.
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APPENDIX A
Journal of Orthopaedic & Sports Physical Therapy®
Downloaded from www.jospt.org at on August 3, 2014. For personal use only. No other uses without permission.
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
GUIDELINES FOR EXERCISE PROGRESSION
Physical Therapy
Education: refrain from activity detrimental to recovery, elevate the ankle
and apply ice, use elastic compression to assist with edema control.
Mobility: active range of motion and mobilizing exercises for the foot
and ankle: plantar flexion, dorsiflexion, inversion, and eversion.
Target: 3 sets of 15 repetitions.
Strength: gentle strengthening exercises initially consisting of isometrics:
pushing foot against the wall for inversion, eversion, and plantar flexion, using the other foot for resistance of dorsiflexion (5-second holds
for 5 repetitions in all directions), and scrunching a towel under the
sole of the foot for intrinsic muscles.
Body-weight resistance: heel raises and mini-squats in bilateral standing.
Stretching: calf and heel cord stretches, starting in long sitting, using
a towel to manually provide the stretch; 3 stretches of 30 seconds’
duration.
Balance: 1-legged standing on the injured limb, with arms abducted
and eyes open; 3 sets of 30 seconds’ duration.
Progression
As swelling and bruising decrease, reduce the time spent elevating the
ankle and decrease frequency of ice application.
Progress to greater range of movement, adding holds at the end range
and increasing the duration of holds.
Strengthening exercises progress to isotonic exercises using elastic band
for resistance. Three sets of 15 repetitions to be performed in
all directions, with the goal of achieving muscle fatigue at the end of 3
sets. Increase range of movement, duration of holds at the end range,
and strength level of the elastic band over time. Progress strength of
elastic band when 3 sets of 15 repetitions are completed in the full
range.
Progress to heel raises and mini-squats standing on the injured limb.
Increase time spent in the weight-bearing position.
Progress to standing stretches for gastrocnemius and soleus;
3 stretches of 30 seconds’ duration.
Progress from arms abducted to arms across chest when able to stand
without losing balance, 3 × 30 seconds. Progress eyes open to eyes
closed when able to stand without losing balance, 3 × 30 seconds with
eyes open, arms across chest.
Dynamic balance: standing on balance/wobble board (or pillow) with eyes Options for progression: eyes open to eyes closed, decrease the standing
open; 3 sets of 60 seconds’ duration.
base, throwing and catching a ball, and standing on the injured limb
only.
Functional weight-bearing activities: walking, running, skipping, and
Progress from walking to running/hopping when strength, range of
hopping, according to patient’s activities and participation.
motion, and balance exercises have been progressed fully as above.
Adapted from Bassett SF, Prapavessis H. Home-based physical therapy intervention with adherence-enhancing strategies versus clinic-based
management for patients with ankle sprains. Phys Ther. 2007;87:1132-1143, with permission of the American Physical Therapy Association. This material
is copyrighted, and any further reproduction or distribution requires written permission from APTA.
APPENDIX B
DESCRIPTION OF THRUST/NONTHRUST MANIPULATION TECHNIQUES
Technique
Description of Technique
Rearfoot: distraction
The therapist grasped the dorsum of the patient’s foot
high-velocity
with interlaced fingers. Firm pressure with both
manual physical
thumbs was applied in the middle of the plantar
therapy intervention
surface of the forefoot. The therapist engaged the
restrictive barrier by passively dorsiflexing the ankle
and applying a long-axis distraction. The therapist
pronated and dorsiflexed the foot to fine tune the
barrier. The therapist applied a high-velocity, lowamplitude force in a caudal direction.
Illustration*
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[
research report
]
APPENDIX B
Journal of Orthopaedic & Sports Physical Therapy®
Downloaded from www.jospt.org at on August 3, 2014. For personal use only. No other uses without permission.
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Technique
Description of Technique
Illustration*
Talocrural joint:
The therapist used the left hand to firmly stabilize
anterior-to-posterior
the lower leg at the malleoli. The therapist grasped
low-velocity manual
the anterior, medial, and lateral talus with the right
physical therapy
hand. The therapist applied a low-velocity, anteriorintervention
to-posterior oscillatory force to the talus. Tip: the
therapist used the thigh to help stabilize the foot and
to progressively increase the amount of ankle dorsiflexion. The therapist may need to adjust the amount
of supination/pronation to optimize the technique.
Weight-bearing
The therapist supported the arch of the foot and aptalocrural joint:
plied a stabilizing force (anterior-to-posterior-directanterior-to-posterior
ed force) over the anterior talus. A belt (padded) was
low-velocity manual
placed over the patient’s distal posterior tibia and
physical therapy
fibula and around the therapist’s buttock region. The
intervention
patient was guided into dorsiflexion of the involved
ankle while, simultaneously, the therapist applied
a posterior-to-anterior-directed force to the distal
leg by leaning backward/pulling on the belt. As the
patient dorsiflexes more, the therapist should squat
down while leaning back to keep a direct posteriorto-anterior force at the talocrural joint (therefore
following the plane of the joint).
Lateral glides and
Talocrural joint lateral glide: the therapist grasped the
eversion: lowmalleoli just proximal to the talocrural joint with
velocity manual
the left index finger/thumb and used the forearm
intervention
to stabilize the patient’s left leg against the table.
The therapist placed the right thenar eminence on
the talus just distal to the malleoli and grasped the
rearfoot. The therapist used his body to impart a
low-velocity oscillatory force to the talus through the
right arm and thenar eminence.
Subtalar joint lateral glide: the therapist shifted the left
hand/forearm distally and grasped the talus with
the left index finger/thumb. The therapist placed
his right thenar eminence on the patient’s medial
aspect of the calcaneus and grasped the rearfoot.
The therapist used his body to impart a low-velocity
oscillatory force to the calcaneus through the right
arm and thenar eminence.
Proximal tibiofibular
The therapist placed his second MCP in the popliteal
joint: high-velocity
fossa, then pulled the soft tissue laterally until the
manual intervention
MCP was firmly stabilized behind the patient’s fibular head. The therapist used the left hand to grasp
the foot and ankle. The therapist externally rotated
the leg and flexed the knee to the restrictive barrier.
Once the restrictive barrier was met, the therapist
applied a high-velocity, low-amplitude force through
the tibia (directing the patient’s heel toward his ipsilateral buttock).
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APPENDIX B
Journal of Orthopaedic & Sports Physical Therapy®
Downloaded from www.jospt.org at on August 3, 2014. For personal use only. No other uses without permission.
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Technique
Description of Technique
Distal tibiofibular joint: The therapist grasped and stabilized the distal tibia
low-velocity manual
with 1 hand. The therapist placed the thenar emiintervention
nence over the lateral malleolus and used his body
to impart a low-velocity, oscillatory, anterior-toposterior force to the fibula on the tibia.
Illustration*
Abbreviation: MCP, metacarpophalangeal joint.
*Images reproduced with kind permission of Evidence in Motion (http://www.evidenceinmotion.com/).
BROWSE Collections of Articles on JOSPT’s Website
The Journal’s website (www.jospt.org) sorts published articles into more
than 50 distinct clinical collections, which can be used as convenient entry
points to clinical content by region of the body, sport, and other categories
such as differential diagnosis and exercise or muscle physiology. In each
collection, articles are cited in reverse chronological order, with the most
recent first.
In addition, JOSPT offers easy online access to special issues and features,
including a series on clinical practice guidelines that are linked to the
International Classification of Functioning, Disability and Health. Please
see “Special Issues & Features” in the right-hand column of the Journal
website’s home page.
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